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Disc-O-Tech Medical Technologies, Ltd.
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SKY BONE EXPANDER SYSTEM is an FDA 510(k)-cleared medical device (K034037) manufactured by Disc-O-Tech Medical Technologies, Ltd.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 27, 2004. Regulation: 8.